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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00441064 |
This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Aliskiren |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Blinded Endpoint, Multi-Center, Cross-Over Study to Evaluate the Effect of High and Low Sodium Diets on Reduction in Mean 24-Hour Ambulatory Blood Pressure in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) |
Estimated Enrollment: | 122 |
Study Start Date: | January 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Novartis US | |
Orangevale, California, United States | |
United States, Minnesota | |
Novartis US | |
Brooklyn Center, Minnesota, United States | |
United States, Montana | |
Novartis US | |
Missoula, Montana, United States | |
Novartis US | |
Butte, Montana, United States | |
United States, Nebraska | |
Novartis US | |
Lincoln, Nebraska, United States | |
United States, New York | |
Novartis US | |
Johnson City, New York, United States | |
United States, North Carolina | |
Novartis US | |
Shelby, North Carolina, United States | |
Novartis US | |
Asheboro, North Carolina, United States | |
United States, Ohio | |
Novartis US | |
Cincinnati, Ohio, United States | |
Novartis US | |
Kettering, Ohio, United States | |
United States, Pennsylvania | |
Novartis US | |
Downington, Pennsylvania, United States | |
Novartis US | |
Pittsburg, Pennsylvania, United States | |
Novartis US | |
Erie, Pennsylvania, United States | |
United States, Texas | |
Novartis US | |
Dallas, Texas, United States | |
Novartis US | |
Kingsport, Texas, United States | |
United States, Utah | |
Novartis US | |
Salt Lake City, Utah, United States | |
Novartis US | |
Bountiful, Utah, United States | |
United States, Washington | |
Novartis US | |
Port Orchard, Washington, United States | |
United States, Wisconsin | |
Novartis US | |
Madison, Wisconsin, United States |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSPP100AUS02 |
Study First Received: | February 26, 2007 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00441064 |
Health Authority: | United States: Institutional Review Board |
High blood pressure, hypertension, aliskiren, low sodium diet |
Vascular Diseases Hypertension |
Cardiovascular Diseases |